A Study Investigating Routine Practice of Chronic Thromboembolic Pulmonary Hypertension Management in EMEA Countries

• Register: ClinicalTrials.gov
• Last refreshed on: 30 August 2021
• Main ID: NCT02637050
• Date of registration: 04/12/2015
• Prospective Registration: Yes
• Primary sponsor: Bayer
• Public title: A Study Investigating Routine Practice of Chronic Thromboembolic Pulmonary Hypertension Management in EMEA Countries EMEA CTEPH
• Scientific title: EMEA CTEPH Registry: An International Prospective Registry Investigating the Epidemiology, Diagnosis and Treatment of CTEPH Patients in EMEA Countries
• Date of first enrolment: March 3, 2016
• Target sample size: 231
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02637050
• Study type: Observational

Countries of recruitment

Algeria, Kazakhstan, Kyrgyzstan, Lebanon, Russian Federation, Saudi Arabia, Turkey, United Arab Emirates

Contacts

• Name: Bayer Study Director
• Affiliation: Bayer

Key inclusion & exclusion criteria

Inclusion Criteria:

- Female and male patients = 18 years of age, diagnosed with CTEPH regardless of the
current treatment

- Availability of a signed informed consent

- WHO Pulmonary Hypertension clinical classification Group IV (CTEPH):

1. Right heart catheterization (RHC) results that are in line with both of the
following haemodynamic levels:

- Mean pulmonary arterial pressure (PAP) = 25 mmHg at rest

- Pulmonary arterial wedge pressure (PAWP) = 15 mmHg

2. Confirmation of CTEPH diagnosis by one of the following as recommended by
standard guidelines:

- At least 1 (segmental) perfusion defect(s) in ventilation/perfusion (V/Q)
scan or

- Pulmonary artery obstruction seen by MDCT (multidetector computed
tomography) angiography or

- Pulmonary artery obstruction seen by conventional pulmonary cineangiography
(In case of suspicion/diagnosis of 'sub-acute' Pulmonary Embolism: Patients
who are treated with anti-coagulation for at least 3 months before diagnosis
of CTEPH)

Exclusion Criteria:

- Patients with an underlying medical disorder with an anticipated life expectancy less
than 6 months

- Any medical condition which, in the opinion of the investigator, could jeopardize the
safety of the patient or his/her compliance in the study, or otherwise make the
patient inappropriate for study participation



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Hypertension, Pulmonary

Intervention(s)

Other: Standard of care

Primary Outcome(s)

The haemodynamics parameters of CTEPH patients will be assessed by evaluating the change in measures of PVR between initial and final visit [Time Frame: Up to 3 years]

The haemodynamics parameters of CTEPH patients will be assessed by evaluating the change in measures of mPAP between initial and final visit [Time Frame: Up to 3 years]

The clinical functional parameters of CTEPH patients will be assessed by evaluating the change in measures of WHO Functional Class between initial and final visit [Time Frame: Up to 3 years]

The clinical functional parameters of CTEPH patients will be assessed by evaluating the change in measures of 6MWD between initial and final visit [Time Frame: Up to 3 years]

The haemodynamics parameters of CTEPH patients will be assessed by evaluating the change in measures of Cardiac Index (CI) between initial and final visit [Time Frame: Up to 3 years]

Secondary Outcome(s)

Rate of Pulmonary Hypertension treatments prior to CTEPH diagnosis, at the time of CTEPH diagnosis and at the time of first visit [Time Frame: Up to 3 years]

Changes in CTEPH treatment during the study period [Time Frame: Up to 3 years]

Mortality due to CTEPH and CTEPH related complications [Time Frame: Up to 3 years]

Eligibility for PEA [Time Frame: Up to 3 years]

The total number of days of hospitalization due to CTEPH and CTEPH related complications [Time Frame: Up to 3 years]

Number of healthcare professional visits due to CTEPH and CTEPH related complications [Time Frame: Up to 3 years]

NT-proBNP (N-terminal Propeptide Brain Natriuretic Peptide) levels [Time Frame: Up to 3 years]

Number of patients eligible for Balloon Pulmonary Angioplasty [Time Frame: Up to 3 years]

Number of patients eligible for Pulmonary endarterectomy [Time Frame: Up to 3 years]

Rate of recurrent to persistent subtypes after Pulmonary Endarterectomy [Time Frame: Up to 3 years]

Treatment duration with Pulmonary Hypertension treatments prior to CTEPH diagnosis, at the time of CTEPH diagnosis and at the time of first visit [Time Frame: Up to 3 years]

Time span between onset of symptoms and CTEPH diagnosis [Time Frame: Up to 3 years]

Usage of diagnostic tools of CTEPH patients (Y/N) [Time Frame: Up to 3 years]

Secondary ID(s)

AD 1502

18303

Source(s) of Monetary Support

Please refer to primary and secondary sponsors